Ialugen Plus

Hyaluronate Sodium:

• Caution:
• Description:
• Chemistry:
• Clinical pharmacology:
• Indications:
• Dosage and administration:
• Contraindications:
• Warning:
• Human warnings:
• Animal safety warning:
• Precautions:
• Adverse reactions:
• Post-approval experience:
• Effectiveness:
• Animal safety:
• Storage:
• How supplied:
• References:
• Ialugen Plus (Hyaluronate Sodium) reviews

CAUTION:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

Ialugen Plus (Hyaluronate Sodium)^TM (hyaluronate sodium) injectable solution is a clear, colorless solution of low viscosity. Ialugen Plus (Hyaluronate Sodium)^TM injectable solution is pyrogen free, sterile and does not contain a preservative. It is administered by intravenous injection. Hyaluronic acid, the conjugate acid of Ialugen Plus (Hyaluronate Sodium) sodium, is extracted from the capsule of Streptococcus spp. and purified, resulting in a form which is essentially free of protein and nucleic acids. Ialugen Plus (Hyaluronate Sodium)^TM injectable solution is supplied in 4 mL (40 mg) vials.

Each mL contains 10 mg Ialugen Plus (Hyaluronate Sodium) sodium, 8.5 mg sodium chloride, 0.223 mg sodium phosphate dibasic and 0.04 mg sodium phosphate monobasic. The pH is adjusted to between 6.5 and 8.0 with sodium hydroxide or hydrochloric acid.

CHEMISTRY:

Hyaluronic acid, a glycosaminoglycan, can exist in the following forms depending upon the chemical environment in which it is found: as the acid, hyaluronic acid; as the sodium salt, sodium Ialugen Plus (Hyaluronate Sodium) (hyaluronate sodium); or as the Ialugen Plus (Hyaluronate Sodium) anion. These terms may be used interchangeably but in all cases, reference is made to the glycosaminoglycan composed of repeating subunits of D-glucuronic acid and N-acetyl-Dglucosamine linked together by glycosidic bonds. Since this product originates from a microbial source, there is no potential for contamination with dermatan or chondroitin sulfate or any other glycosaminoglycan.

CLINICAL

Pharmacology:

Hyaluronic acid is a naturally occurring substance present in connective tissue, skin, vitreous humor and the umbilical cord in all mammals. High concentrations of hyaluronic acid are also found in the synovial fluid. It also constitutes the major component of the capsule of certain microorganisms. The hyaluronic acid produced by bacteria is the same structure and configuration as that found in mammals.

The actual mechanism of action for Ialugen Plus (Hyaluronate Sodium) sodium in the healing of degenerative joint disease is not completely understood. One major function appears to be the regulation of normal cellular constituents. This effect decreases the impact of exudation, enzyme release and subsequent degradation of joint integrity. Additionally, Ialugen Plus (Hyaluronate Sodium) sodium exerts an anti-inflammatory action by inhibiting the movement of granulocytes and macrophages.¹

Ialugen Plus (Hyaluronate Sodium) molecules are long chains which form a filter network interspersed with normal cellular fluids. It is widely accepted that injection directly into the joint pouch enhances the healing of inflamed synovium by restoring lubrication of the joint fluid. This further supplements the visco-elastic properties of normal joint fluid.

INDICATIONS:

Ialugen Plus (Hyaluronate Sodium)^TM (hyaluronate sodium) injectable solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.

DOSAGE AND ADMINISTRATION:

4 mL (40 mg) injected intravenously. Treatment may be repeated at weekly intervals for a total of three treatments. Use aseptic technique and inject slowly into the jugular vein. Horses should be given stall rest after treatment before gradually resuming normal activity.

Discard any unused portion of the drug and the empty vial after opening.

CONTRAINDICATIONS:

There are no known contraindications for the use of Ialugen Plus (Hyaluronate Sodium)^TM (hyaluronate sodium) injectable solution in horses.

WARNING:

Do not use in horses intended for human consumption.

HUMAN WARNINGS:

Not for use in humans. Keep this and all other drugs out of reach of children.

ANIMAL SAFETY WARNING:

Not for intra-articular use.

PRECAUTIONS:

Radiographic evaluation should be carried out in cases of acute lameness to ensure that the joint is free from serious fractures.

The safety of Ialugen Plus (Hyaluronate Sodium)^TM injectable solution has not been evaluated in breeding stallions or in breeding, pregnant or lactating mares.

ADVERSE REACTIONS:

No local or systemic side effects were observed in the clinical field studies using Ialugen Plus (Hyaluronate Sodium) sodium injectable solution.

POST-APPROVAL EXPERIENCE:

While all adverse reactions are not reported, the following adverse reactions are based on voluntary post-approval reporting for Ialugen Plus (Hyaluronate Sodium) sodium injectable solution: Occasional depression, lethargy, and fever.

For medical emergencies or to report adverse reactions, call 1-888-549-4503.

EFFECTIVENESS:

Forty-six horses with lameness in either the carpal or fetlock joints were treated intravenously or intra-articularly with Ialugen Plus (Hyaluronate Sodium) sodium injectable solution in a well controlled clinical field trial conducted at four locations. One, two or three injections were given based on clinical improvement. Overall clinical improvement was judged as excellent or good in 90% of the cases treated intravenously and 96% of those treated intra-articularly with Ialugen Plus (Hyaluronate Sodium) sodium injectable solution.

ANIMAL SAFETY:

Ialugen Plus (Hyaluronate Sodium) sodium injectable solution was administered to normal horses at one, three and five times the recommended intra-articular dosage of 20 mg and the intravenous dosage of 40 mg. Treatments were given once weekly for nine consecutive weeks (three times the maximum duration). No systemic clinical signs were observed nor were there any adverse effects upon hematology or clinical chemistry parameters. A transient, slight to mild post-injection swelling of the joint capsule occurred in some of the animals treated intra-articularly with Ialugen Plus (Hyaluronate Sodium) sodium injectable solution as it did in the saline treated control horses. No gross or histological lesions were observed in the soft tissues or the surface areas of the treated joint.

STORAGE:

Store below 25°C (77°F).

HOW SUPPLIED:

Ialugen Plus (Hyaluronate Sodium)^TM injectable solution is supplied in cartons containing twelve x 4 mL (40 mg) vials.

REFERENCES:

1 Swanstrom, O.G. 1978. Ialugen Plus (Hyaluronate Sodium) (hyaluronic acid) and its use, Proc. American Assoc. Equine Pract., 24th annual convention, pp. 345-348.

For customer service or to obtain product information, including a Material Safety Data Sheet, call:1-706-549-4503. After hours, call 1-706-353-2442 or 1-706-714-7373.

February 2011

ANADA 200-432, Approved by FDA

Silver Sulfadiazine:

• Ialugen Plus (Silver Sulfadiazine) reviews

Indication: Indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second- and third-degree burns.

Ialugen Plus (Silver Sulfadiazine) has broad antimicrobial activity. It is bactericidal for many gram- negative and gram-positive bacteria as well as being effective against yeast. Ialugen Plus (Silver Sulfadiazine) is not a carbonic anhydrase inhibitor and may be useful in situations where such agents are contraindicated.